According to WHO, the prevalence of malaria is between 300-500 million cases worldwide, while approximately 30% of the human population is expected to be infected with tuberculosis. While malaria primarily affects the poorest regions of the world, tuberculosis (TB) is more widespread in both developing and developed countries. Tuberculosis is a global disease, which pose such a big problem that the World Health Organization in 1993 ruled disaster alarm. The majority of tuberculosis sufferers are found in the third world countries, in particular Africa and Southeast Asia, but there are also cases of tuberculosis in western countries, both among natives and immigrants. The global mobility of tuberculosis is increased due to global traffic and tourism, and the problems of the global prevalence of tuberculosis is underscored by the high prevalence of multidrug-resistant tuberculosis that can not be treated with traditional medicine, in particular the Baltic countries.
On a world wide scale, about two to three million people die every year, in particular children and young people. WHO estimated in 2000 that approx. 33% of the world population (about 2 billion people) is infected with tuberculosis; of these, approx. 5-10% develop the disease at some point in their lifetime.
Tuberculosis is an infectious disease caused by inhalation of tuberculosis bacteria (Mycobacteria tuberculosis). These bacteria attack primarily the lungs, and cause a slight infection during the first six weeks without any serious symptoms. From the lungs, the bacteria can spread through the bloodstream to other organs, although still without necessarily doing any damage at first. In many cases, the infection is fought, if the infected person has a good immune system, however, months or years later, the disease may break out in both lungs and other organs if the immune system is weakened for various reasons. Today, outbreak of tuberculosis often occurs in connection with immune system weakening associated with HIV infection, in particular on the African continent. If tuberculosis is spread further in western countries, tuberculosis outbreak are likely to occur also among cancer patients and other patients, where the immune system is challenged.
A person with active tuberculosis infects on average 10 to 15 other people. Infection occurs through the air with tuberculosis bacteria in saliva droplets from cough or sputum from the patient being inhaled by others. Symptoms of tuberculosis such as heavy coughing and spitting does at least in the initial phases of the disease appear very alarming. The danger of infection is especially high in highly populated areas. The increasing global urbanization combined with increased migration is therefore an important factor in the rising number of tuberculosis cases worldwide.
Among the most important factors in fighting the spread of tuberculosis are effective and rapid methods of diagnosis so that persons with active and infectious tuberculosis can be isolated and subject to treatment. Already after fourteen days of antibiotic treatment, the risk of further transmission of the disease is prevented. To halt the spread of antibiotic resistant tuberculosis bacteria and to curb the spread of infection, WHO recommends a treatment strategy to reduced the DOTS (Directly Observed Treatment Short Course) which provides control and monitoring of patients and as such requires a safe, effective and rapid diagnosis of the disease. One of the problems when it comes to slow the spread of tuberculosis is that it has not yet succeeded in developing diagnosis methods that meet the necessary criteria, such as efficient at-bed-side diagnostic tools. Current diagnosis of TB relies on advanced instrumentation and facilities. Furthermore, diagnostics involve a several day long procedure. The method of the present invention, by contrast, is based on simple technology and can be performed and read-out at the bed-side within a few hours, provided that suitable platform development is achieved. When considering that each untreated TB patient on average transfers the infection to 10-15 other persons, early diagnosis allowing early treatment, which immediately prevents transfer of the disease, is of utmost importance.